NCT05924165

Narcotic-Free Percutaneous Nephrolithotomy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized control trial comparing oral ketorolac and opioid medication for the use of post-operative analgesia.

Detailed description

This is a randomized control trial comparing oral ketorolac (10mg, Q6 PRN) and oxycodone (5mg, Q6 PRN) medication for the use of post-operative analgesia after kidney stone removal surgery called percutaneous nephrolithotomy (PCNL). Primary endpoints are visual analog pain scores (VAS) for days 1-5 and day 10 post operatively. Secondary endpoints are pill counts, patient-related outcome survey (PROMIS) scores, emergency room visits, and patient telephone calls. 90 subjects will be enrolled, with 45 in each group.

Conditions

• Nephrolithiasis

Interventions

Type	Name	Description
DRUG	5mg Oxycodone, Q6 PRN	Oxycodone is an opioid that is used to relieve moderate to severe pain.
DRUG	10mg Ketorolac, Q6 PRN	Ketorolac is an NSAID used to relieve moderately severe pain.

Timeline

• Start date: 2023-05-19
• Primary completion: 2025-01-07
• Completion: 2025-01-07
• First posted: 2023-06-29
• Last updated: 2025-03-26
• Results posted: 2025-03-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study